Claris Lifesciences is an IPR driven international pharmaceutical company, in the business of manufacturing and marketing of high end injectables with focus on New Drug Delivery Systems for treatment of critical illnesses and diseases. With emphasis on Quality, Technology & Innovation, Claris offers a range of niche technology Aqueous & Lipid emulsion injectable products across delivery systems such as bottles, vials, ampoules, non-PVC/PVC bags . The company's strength lies in its know-how and expertise in manufacturing and marketing injectable products.Driven by a team of scientists, pharmaceutical experts and management professionals, Claris is powered by a combination of Vision, R&D capabilities, Technological know-how, International standards and Manufacturing expertise , an expanded Proprietary Marketing Network and Ambition to be one of the world's leading and most admired pharmaceutical companies in the global generics space.The company's range of products and delivery systems extends across Enteral and Parenteral Nutrition, Anaesthesia, Blood Products and Plasma Volume Expanders, Anti-infectives, Dialysis and Transplant, Oncology & Infusion Therapy. Claris enjoys Market Leadership in India. Globally, the company operates in more than 76 countries, through its subsidiaries, offices and marketing/distribution network, and a diverse customer profile covering institutions, large corporate hospitals and international aid agencies.

Role & Responsibilities:

To be a part of the quality leadership team and work with management for devising strategies.

To formulate and execute strategy on quality management to ensure that the manufacturing facility is continuously in compliance with GMP.

To formulate & execute strategy for continuous enhancement of Quality Management System(QMS) in-line with the new trends in the industry and proactively upgrade QMS to be in compliance with the new guidelines.

To manage the overall quality assurance by reviewing all plant-related documents & processes of the manufacturing organisation on an ongoing basis.

To travel to the manufacturing facility regularly and continue to monitor, update, and ensure that the plant is in compliance with all the expectations of FDA.

To enhance, upgrade and improve quality management system at the facility.

To review the Quality Assurance documents and ensure that the document quality leads to ANDA approvals within stipulated time with minimal deficiencies.

To review and study various industry trends such as warning letters and 483s given to other companies; attend industry events and conferences; and remain abreast with new guidelines from FDA and work on preventive actions so as to proactively avoid such observations in our own manufacturing organisation.

To plan and execute continuous evaluation & enhancement programmes related to compliance in-line with Good Manufacturing Practices (GMP) along with the team in India.

To review, analyse, and evaluate Quality Management Documents and make corrective & preventive action plans, and work in sync with the team in India for the closure of the same.

To identify trends in rejections, deviations, Out of Specification reports, annual product reviews, complaints, CAPA, Change control; and analyse, investigate and make required action plans to work with the Indian counterparts to conclude root-cause analysis with risk mitigation plan.

To review the Quality Governance Systems and continuously enhance them to increase management bandwidth of the quality organisation to align with the opportunities for growth.

To review the organisational design & effectiveness of the quality team and formulate & implement various training & organisational development programmes along with management.

To impart training to the quality & manufacturing teams of all the manufacturing organisations to enhance knowledge and skills of the members.

Experience :

18+ years in the field of corporate quality assurance, including 10+ years in site quality assurance in sterile manufacturing facilities; should have faced USFDA audits; and should have experience in working with Indian manufacturing facility.